TheraSphere
FDA premarket approval P200029/S007 · decided 2023-12-18
Approval details
- PMA number
- P200029
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TheraSphere
- Generic name
- Microspheres radionuclide
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-11-27
- Decision date
- 2023-12-18
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- the manufacturing change to allow the ball mill to be used as an optional alternative to the mortar and pestle in the final frit crushing step.
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